Summary

This randomized, placebo-controlled trial aims to determine the effects of daily
administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on
cardiovascular health biomarkers, microbiota composition and functioning and intestinal
barrier function in overweight subjects.

The effect on fecal microbial community composition measured by fecal microbial community composition

time frame:
6 weeks

The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)

time frame:
6 weeks

Effect on gut barrier function measured by a sugar test

time frame:
6 weeks

To assess the bioavailability of PD01 by measuring blood carotenoid concentration

time frame:
6 weeks

Effect on digestive tolerance measured by GSRS questionnaire

time frame:
6 weeks

Effect on digestive tolerance measured by Bristol Stool Chart

time frame:
6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria:
- Overweight men/women (BMI 25-35 kg/m2)
- Healthy individuals
- Age between 18 and 70 years
- Fasting glucose < 7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
Exclusion Criteria:
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- History of (severe) cardiovascular, respiratory, urogenital,
gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose,
throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional,
endocrine, neurological diseases, allergy, major surgery and/or laboratory
assessments which might limit participation in or completion of the study protocol.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the
principle investigator)
- Use of medication interfering with endpoints
- Use of antioxidants, minerals and vitamin supplements available in pharmacies,
drugstores, food markets or in alternative medicine
- Administration of investigational drugs or participation in any scientific
intervention study which may interfere with this study (to be decided by the
principle investigator), in the 180 days prior to the study
- Use of antibiotics in the 90 days prior to the start of study
- Known pregnancy, lactation
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- Smoking
- Blood donation within 3 months before study period
- Plans to lose weight or following a hypocaloric diet during the study period;
- Weight gain or loss > 3 kg in previous 3 months
- High physical activity (>4.5 hours of running/week)
- Hormone replacement therapy (women)
- History of any side effects towards intake of pro- or prebiotic supplements of any
kind
- History of any side effects towards intake of carotenoids
- Prohibited use of pro-, pre- or synbiotics during study period and from one month
prior to start of study.
- High intake of fruits and vegetables (more than the 75th percentile of dietary intake
of fruits and vegetables)
- Vegetarians/vegans

Additional Information

Official title

The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment

Principal investigator

Ad Masclee, MD

Trial information was received from ClinicalTrials.gov and was last updated in December 2015.

Information provided to ClinicalTrials.gov by Maastricht University Medical Center.